Events

Rappel de Device Recall ZeroP StarDrive Screwdriver Shaft

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Synthes Spine.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    51781
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1348-2009
  • Date de mise en oeuvre de l'événement
    2009-02-10
  • Date de publication de l'événement
    2009-06-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-10-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81257
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    screwdriver instructions - Product Code ODP
  • Cause
    Tip breakage, due to inadequate instructions for use. the technique guide provided incorrect information related to use of the torque limiting attachment during screw insertion and final tightening.
  • Action
    All affected Synthes Spine Sales Consultants were notified of the Labeling Correction via email on February 10, 2009. They were instructed to review changes with their surgeons. They were supplied with an electronic version of the corrected Technique Guide on March 11, 2009. All affected Synthes Sales Consultants and Customers were notified of this labeling change via distribution of the updated Technique Guide and a notification letter. This packet was sent via USPS certified mail on March 26, 2009. To ensure a broad and accurate distribution of notification, affected consultants and customers are defined as having been shipped Zero-P 3.0 mm Titanium Cervical Spine Locking Screws. These devices are used only with the Zero-P system.

Device

Device Recall ZeroP StarDrive Screwdriver Shaft
  • Modèle / numéro de série
    Catalog # 03.617.902 - All lots
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed Nationwide and Canada.
  • Description du dispositif
    Synthes Zero-P StarDrive Screwdriver Shaft, T8, self-retaining, quick coupling, for use in spinal fusion surgery. Catalog # 03.617.902 Technique Guide.
  • Manufacturer
    Synthes Spine

Manufacturer

Synthes Spine
  • Adresse du fabricant
    Synthes Spine, 1302 Wrights Ln E, West Chester PA 19380-3417
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA